The Food and Drug Administration’s push to ensure that healthcare facilities stockpile single-use N95 respirators has arrived while some workers continue to lack access to the equipment and U.S. mask manufacturers can’t find enough buyers, according to a report from Kaiser Health News.
The FDA’s effort, detailed in a letter to healthcare workers and facility operators, is an early move toward phasing out pandemic-era rules that allow decontamination and reuse of disposable masks, the new outlet was told.
“That was never intended to be anything other than a crisis measure,” Suzanne Schwartz, director of the FDA’s Office of Strategic Partnerships and Technology Innovation, said in an interview. “We want to be sure healthcare facilities are getting themselves in a situation where they have respirators or reusables in stock.”
But the reality of mask availability on the ground remains complicated. According to KHN investigator Christina Jewett:
- In January, federal officials approved the export of U.S. N95s amid mounting unsold inventory, a move a nurses union leader called “unconscionable.”
- In February, prominent scientists appealed to the White House to help protect a broader swath of U.S. workers from the airborne risk virus.
- On March 1, U.S. mask-manufacturers wrote to President Joe Biden about a glut of respirators that were made in the United States and sitting unused in warehouses.
- A new, U.S.-based mask manufacturer told the news outlet that he has been shocked by his company’s inability to break into a U.S. market dominated by large group-purchasing organizations and an ingrained preference to buy from China. And 50 U.S. mask-makers reported in a survey that they’ve collectively laid off workers in recent months amid sluggish demand. Some companies are expected to fail.
Meanwhile, healthcare workers have borne a heavy burden from COVID-19 infections, and nursing home care providers appear to have the sad distinction of accounting for a large proportion of those deaths, according to an investigation by KHN and The Guardian. Many were people of color.
“In interviews with families and colleagues, dozens raised concerns about inadequate protective gear,” the news outlet reported.
Officials take small steps toward a fix
Federal health officials appear to be taking steps to rectifying these issues. The Centers for Disease Control and Prevention has approved models of elastomeric respirators that are meant to be reused, and will add 375,000 to the Strategic National Stockpile. “This might serve to protect more healthcare workers in the case of a variant surge or new pandemic,” Jewett wrote.
The CDC has also changed its guidelines, saying N95 masks are “prioritized” rather than “reserved” for healthcare workers, and may be sold in bulk to other employers to potentially boost demand, the news outlet reported. The agency also will allow major retailers to sell N95s to businesses outside the health care sector, it added.
But the changes don’t yet approach what’s needed to keep nurses, for example, fully protected, said Jane Thomason, lead industrial hygienist for National Nurses United.
The full report can be found here.